A CDSCO expert panel has sought clarifications from Serum Institute of India (SII) over its application to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 2 and 3 human clinical trials of the Oxford vaccine candidate for COVID-19, said official sources.
The Subject Expert Committee (SEC) on COVID-19 which held its meeting on Tuesday deliberated on the application by SII and asked the firm to revise its protocol for the phase 2 and 3 clinical trials, besides seeking some additional information.
On Wednesday evening, SII submitted a revised protocol for conducting the trials to the DCGI.
“The company was asked to clearly define phase 2 and phase 3 part of the protocol and resubmit their application for evaluation by the SEC,” an official source said.
The panel also recommended that the proposed clinical trial sites be distributed across India, the source said.
“They also have not given justification for the proposed enrolment of 1,600 subjects during the trial,” the source added.
Prakash Kumar Singh, Additional Director, Government Affairs, SII, said, “We have submitted our revised protocol to DCGI office today evening for further action by SEC and DCGI.”
The SII which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its application to the DCGI on Friday, seeking permission for conducting the phase 2 and 3 trials of the potential vaccine ”Covidshield”.
The firm plans to start phase 2 and 3 human trials in India in August.